Medical Device Registration and Approval in Indonesia

General country-specific regulatory information is provided on this page for medical device registration and approval in Indonesia. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Indonesia, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Indonesia

 

REGULATORY AUTHORITYMinistry of Health (MoH)

CLASSIFICATION SYSTEM: Medical Devices/IVDs: Class A/B/C/D or 1/2/3

TIMEFRAME: 

Medical Devices/IVDs – Official Timeline:

Class A – 45 working days

Class B/C – 60 working days

Class D – 80 working days

Medical Devices/IVDs – Actual Timeline (based on experience):

Class A – 1 to 2 months

Class B/C – 3 to 4 months 

Class D – 4 to 6 months

SPECIAL REQUIREMENTS:

On-site Audit: Not required.

Local Tests/Permit: May be required for some devices such as disposable sterile syringes, HIV test products, medical devices that contain/transmit radiation, medical devices that transmit radiofrequency/Bluetooth.

Local Clinical Evaluation or Studies: Not required.

LOCAL FEES (New Application):

Medical Devices & In-vitro Diagnostics (IVDs)

Class A: USD $100

Class B/C: USD $200

Class D: USD $333

LOCAL FEELS (Manufacturer): No manufacturer registration is required. The local authorized representative, however, must be an establishment that holds a valid Medical Device Distributor License (MDDL) and implements a Good Distribution Practice of Medical Device (GDPMD). 

LICENSE VALIDITY: Maximum 5 years (depending on the validity of authorization letter issued by the foreign manufacturer).

LICENSE TRANSFER: License transfer is possible but new registration is required.

AUTHORIZED REPRESENTATIVE:  A solely local authorized representative should be appointed by an overseas manufacturer through official Letter of Authorization (LoA).

Last updated on November 5, 2020

Other Southeast Asian Countries:

CambodiaMalaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam

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